MONDAY, June 28 (HealthDay News) -- A new study suggests that men who take the cholesterol-lowering drugs known as statins are a third less likely to suffer from recurrences of prostate cancer.

But don't demand that your doctor prescribe a statin -- drugs such as Crestor, Lipitor and Zocor -- for you just yet.

The findings aren't firm enough for doctors to make a blanket recommendation about statin therapy for men who have had prostate cancer, said study senior author Dr. Stephen Freedland, an associate professor of urology and pathology at Duke University.

Another physician went further, saying the findings simply aren't convincing.

Some prior research has suggested that men who took the cholesterol-lowering drugs were less likely than other men to develop advanced prostate cancer and have it come back. But other studies haven't found such positive effects, so the jury is still out, said Dr. Nelson Neal Stone, a professor of urology and radiation oncology at Mount Sinai School of Medicine.

The goal of the new study was to see if statins might be helping those who had already had the disease.

The researchers examined the medical records of more than 1,300 men who'd had their prostates removed after being diagnosed with prostate cancer. Of those, 18 percent were taking a statin when they had the procedures.

The study results appear in the June 28 online issue of the journal Cancer.

After adjusting their statistics so they wouldn't be thrown off by factors such as high or low numbers or who were, say, obese or older, researchers found that those on statins were 30 percent less likely to suffer a recurrence of prostate cancer. More specifically, tumors recurred in 25 percent of those who didn't use statins and 16 percent of those who did.

The study doesn't prove a cause-and-effect relationship: The statins did not necessarily directly lower the risk of prostate cancer recurrence, the experts note. To confirm whether a drug actually reduces risk, researchers rely on studies -- unlike this one -- that randomly assign patients to certain treatments.

Stone added that the study has statistical problems that make its results questionable.

Still, men did better if they took higher doses of statins, Freedland said, suggesting that the drugs may have an effect. They may work by reducing inflammation that spurs tumor growth, he theorized.

Statins are among the most widely prescribed drugs in America, but they do come with risks. Patients may develop liver problems and muscle damage, although the likelihood of that is low, Freeland said.

And the drugs aren't as inexpensive as, say, aspirin. Statins can cost $5 a day or more, depending on dose, although some are much cheaper.

However, not every prostate cancer patient may need to take them, Freedland said. Tests at the time of surgery can estimate a man's risk of prostate cancer recurrence, and statins would be most appropriate for those at highest risk, he explained.

For now, Freedland doesn't recommend that prostate cancer patients start taking statins to prevent recurrence. However, "if you're already on a statin, I'd keep you on that statin," he said. "If you have a clear-cut indication, the benefits outweigh the risks."

MONDAY, June 28 (HealthDay News) -- Toddlers who receive the combination MMRV (measles, mumps, rubella and varicella) vaccine are at higher risk of having a febrile seizure a week to 10 days after receiving the shot than children who get the MMR and varicella (chicken pox) vaccines separately at the same visit, a new study confirms.

Although the combination shot doubles the risk of febrile seizure, the odds are still quite small, experts noted.

"What's important for parents to understand is that even though there's a doubling of the risk for the combination vaccine, the overall risk of seizure to any one child with any measles-containing vaccine is still less than one in 1,000 doses," said Dr. Nicola Klein, co-director of the Kaiser Permanente Vaccine Study Center in Oakland, Calif., and lead investigator of the study, published online June 28 and in the July print issue of Pediatrics.

The study, funded by the U.S. Centers for Disease Control and Prevention, involved the health records of more than 459,000 children who received their first dose of measles-containing vaccine between 2000 and 2008. The data came the Vaccine Safety Datalink (VSD), a vaccine safety surveillance system sponsored by the CDC and comprised of health records from eight managed care organizations across the country.

Researchers found that among 12- to 23-months olds who received their first dose of measles-containing vaccine, the MMRV shot resulted in one additional febrile seizure for every 2,300 doses given when compared with separate MMRV and varicella vaccines.

Febrile seizures are brief convulsions brought on by fever that occur in about 5 percent of children between 6 months and 5 years of age, said Klein. Although the seizures are distressing, especially to parents, they don't lead to epilepsy or seizure disorders.

The findings are a follow-up to preliminary findings on the twofold increased risk of febrile seizures, which Klein and her colleagues reported to the CDC's Advisory Committee on Immunization Practices (ACIP) in February 2008. Soon afterward, the ACIP changed its recommendations from a stated preference for the MMRV vaccine to no preference for either MMRV or separate MMR and varicella vaccines.

"The reason we did the larger study was to confirm the finding of the twofold increased risk, and to evaluate seizures that occurred at other times, and we found no increased risk outside the seven-to-10-day window," said Klein.

The MMRV vaccine, made by Merck & Co., was licensed by the U.S. Food and Drug Administration in 2005, for use in children aged 12 months to 12 years. The first dose was recommended at 12 to 15 months, and the second at 4 to 6 years. Since 2007, the vaccine has been unavailable because of manufacturing problems, but the company recently began taking orders for it again. Many clinics and doctors offices still had the vaccine in stock for much of 2008.

Dr. Wendy Sue Swanson, a pediatrician in Mill Creek, Wash., who is also on staff at Seattle Children's Hospital, said she was initially a big proponent of the MMRV vaccine but began counseling parents about the increased risk of febrile seizures as soon as the preliminary findings were made public and the ACIP changed its recommendation.

"I would say, 'There's a new report out that says seizures are twice as likely with this combination vaccine, but they're still really rare,' and every person chose to separate the vaccines," said Swanson. "Parents thought it was worth an extra 20 seconds of discomfort if they could protect their kids from these diseases equally well with two shots and reduce the risk of seizures."

"My job as a pediatrician is to help families decrease side effects and risks," added Swanson, herself a parent of two young children. "One in 2,300 is nearly nil, but it's not entirely nil. And nobody wants their child to be that one."

Partly because of the findings of this larger study, the CDC last month released new recommendations for the MMRV vaccine, stating that all children with a personal or family history of seizures should get the separate MMR and varicella vaccines. The CDC also said that, although either the MMRV or the separate MMR and varicella vaccines may be used as the first dose for children aged 12 to 47 months, health care providers should give separate vaccines for the first dose "unless the parent or caregiver expresses a preference for MMRV vaccine."

A colleague began a recent presentation by asking the audience, “How many of you have had a colonoscopy?”

The majority of participants raised their hands.

Then he asked, “How many of you assumed that the instruments used during your procedure were truly clean?”

All raised their hands again.

Then, he asked, “How would you feel if you found out two weeks, or even a year later, that you may have contracted a severe illness because the tools used were contaminated?”

Silence…

No one expects that receiving healthcare will make them sicker instead of well. ‪

Healthcare-associated infections (HAIs) are a significant concern that affects all types of patients in all kinds of settings including hospitals, surgery centers, dialysis clinics, community clinics, long-term care facilities and more. While we know that the financial cost and, more importantly, the emotional and physical toll of these infections is huge, HAIs were historically accepted as part of routine care. Certainly, not many people outside of the medical and public health communities knew much about what we now know are largely preventable infections.

‪In recent years, however, there has been a momentum building to incorporate more accountability, transparency, and patient empowerment into our healthcare system. With that movement came interest in having HAIs reported publicly, a stance that CDC supports. In fact, we published a statement on the topic in February 2010. Several states have laws that mandate public disclosure of infection rates and certain healthcare facilities, and we expect that trend to expand quickly. In addition, CDC began this year publishing state specific HAI information, and we will report again this fall and include more infection types and all states.‪Public reporting of HAIs has had many intended and unintended consequences. In addition to providing increased transparency, infection prevention professionals are telling us that they are getting more support for their prevention efforts. Intense focus on HAI prevention has patients asking about infection rates and other safe healthcare issues. We’ve also heard that some healthcare professionals are not in favor of this type of reporting.

‪What is your take on public reporting? How has it been handled in your organization? What impact has it had?

NIDDK Communications Office301-496-3583 NIH-Supported ACCORD Eye Study Finds Two Therapies Slow Diabetic Eye Disease ProgressionIn high-risk adults with type 2 diabetes, researchers have found that two therapies may slow the progression of diabetic retinopathy, an eye disease that is the leading cause of vision loss in working-age Americans.

Results of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study, supported by the National Institutes of Health, are published online June 29 in the New England Journal of Medicine (NEJM) and will be presented June 29 at the 70th Scientific Sessions of the American Diabetes Association.

"The ACCORD Eye Study clearly indicates that intensive glycemic control and fibrate treatment added to statin therapy separately reduce the progression of diabetic retinopathy," said Emily Chew, M.D., chair of the Eye Study and chief of the Clinical Trials Branch of the Division of Epidemiology and Clinical Applications at the National Eye Institute (NEI). "The main ACCORD findings showed that fibrate treatment added to statin therapy is safe for patients like those involved in the study. However, intensive blood sugar control to near normal glucose levels increased the risk of death and severe low blood sugar, so patients and their doctors must take these potential risks into account when implementing a diabetes treatment plan."

The ACCORD study was a landmark clinical trial that included 10,251 adults with type 2 diabetes who were at especially high risk for heart attack, stroke or cardiovascular death. The study evaluated three intensive strategies compared with standard treatments for lowering cardiovascular risks associated with diabetes.

Intensive treatments included control of blood sugar to near normal levels, control of blood pressure to normal levels, and combination treatment of multiple blood lipids with fenofibrate and simvastatin compared to standard treatment with simvastatin alone. Fenofibrate treatment lowers triglycerides and raises the "good" high density lipoprotein (HDL) cholesterol levels, while simvastatin lowers the "bad" low density lipoprotein (LDL) cholesterol levels. All participants were enrolled in the blood sugar trial and in either the blood pressure or lipid trial.

The ACCORD Eye Study involved a subset of 2,856 participants. Researchers analyzed the effects of the treatment strategies on blood vessels in the eye by identifying diabetic retinopathy progression over four years. Diabetic retinopathy is a disease in which blood vessels in the eye’s light-sensitive retinal tissue are damaged by diabetes. Blood vessels can begin to leak, causing swelling in the retina, and abnormal new blood vessels can develop, both causing vision loss. In the study, disease progression was identified through retinal photographs that indicated blood vessel changes or by the need for laser or eye surgery to treat abnormal blood vessels.

Compared with standard blood sugar control, intensive control decreased the progression of diabetic retinopathy by about one-third, from 10.4 percent to 7.3 percent, over four years. Participants in the intensive control group had a median blood sugar level of 6.4 percent hemoglobin A1c—a level close to values in people without diabetes. The standard blood sugar control group maintained a median level of 7.5 percent.

"Previous clinical trials have shown the beneficial effects of intensive blood sugar control on slowing the progression of diabetic retinopathy in people with type 1 diabetes or newly diagnosed type 2 diabetes," said NEI director Paul A. Sieving, M.D., Ph.D. "The ACCORD Eye Study expands these findings to a larger population of adults who had type 2 diabetes for an average of 10 years, and demonstrates that the eye benefits from the reduction of glucose below previously established levels."

In addition, compared with simvastatin treatment alone, combination lipid therapy with fenofibrate plus simvastatin also reduced disease progression by about one-third, from 10.2 percent to 6.5 percent, over four years. No prior clinical trial has shown that the combination of fenofibrate and simvastatin reduces diabetic eye disease progression.

There were no differences in diabetic retinopathy progression among participants treated to an intensive systolic blood pressure (top number in a reading) target of less than 120 mm Hg compared with those treated to a standard target of less than 140 mm Hg.

In the main ACCORD study, none of the three treatment strategies resulted in a significant decrease in the combined rates of heart attack, stroke or cardiovascular death compared with standard treatments. However, over about three-and-a-half years of follow up, participants in the intensive blood sugar group had a 22 percent higher risk of death (5.0 percent versus 4.0 percent) and a three times higher risk of seriously low blood sugar (10.5 percent versus 3.5 percent) compared with participants in the standard blood sugar control group.

The ACCORD study began in 2001, and participants were treated and monitored for an average of five years. Results of the blood sugar clinical trial were reported in 2008, when the intensive blood sugar therapy was stopped 18 months early due to an increased risk of death in that treatment group compared with the standard blood sugar control group. Findings from the blood pressure and lipid clinical trials appeared in the April 29, 2010 edition of NEJM.

"A key question in the main ACCORD study was whether intensive glucose control, previously demonstrated to reduce risk of microvascular disease — including eye problems — in diabetes, would reduce large vessel disease that causes problems like heart attacks. Investigators are continuing to evaluate the risks and benefits of the treatment strategies in these high-risk patients with type 2 diabetes," said Susan B. Shurin, M.D., acting director of the National Heart, Lung, and Blood Institute, the primary sponsor of the ACCORD study. "Clinicians should individualize treatment for each patient to prevent complications, also incorporating information about conditions such as cardiovascular or visual problems. Lifestyle interventions, including physical activity, weight loss and healthy diets, can improve diabetes control and reduce onset of diabetes."

Find more information about this trial (NCT00542178) at www.clinicaltrials.gov. Visit www.nei.nih.gov/health/diabetic for more information about diabetic retinopathy.

The National Heart, Lung, and Blood Institute is the primary sponsor of ACCORD, with additional funding and scientific expertise contributed by the National Institute of Diabetes and Digestive and Kidney Diseases. The ACCORD Eye Study was supported by the National Eye Institute. Another component of the National Institutes of Health — the National Institute on Aging — and the Centers for Disease Control and Prevention support additional substudies. The following companies provided study medications, equipment, or supplies: Abbott Laboratories, Amylin Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare Inc., GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals Inc., Merck & Co. Inc., Novartis Pharmaceuticals Inc., Novo Nordisk Inc., Omron Healthcare Inc., Sanofi-Aventis U.S., and Takeda Pharmaceuticals Inc.

The National Eye Institute, part of the National Institutes of Health, leads the federal government’s research on the visual system and eye diseases. NEI supports basic and clinical science programs that result in the development of sight-saving treatments. For more information, visit www.nei.nih.gov.

Part of the NIH, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include: diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov. The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Aiming for Near-Normal Blood Sugar Did Not Delay Combined Risk of Diabetic Damage for People With Long-standing Diabetes, NIH-Sponsored Trial Finds Some Signs of Damage to Kidneys, Eyes, Nerves Delayed

In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found. The intensive glucose treatment was compared with standard glucose control.

These findings are from the NIH-funded Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Although intensive treatment produced some beneficial changes, this approach was reported in 2008 to increase death rates.

The new ACCORD findings appear June 29, 2010 in The Lancet's special online diabetes issue, coinciding with a presentation of the study results at the American Diabetes Association's 70th annual scientific sessions in Orlando.

Over time, diabetes damages the small blood vessels of the eyes, nerves, kidneys and other organs, leading to pain and disability. Heart disease due to damaged large blood vessels is a major cause of death in persons with type 2 diabetes. The longer a person has diabetes, the greater the chances of serious complications, including vision loss and blindness, foot ulcers and amputations, kidney disease and kidney failure, and heart disease and stroke.

"In these ACCORD participants with established type 2 diabetes and additional risk factors for cardiovascular disease, intensive lowering of blood glucose reduced some markers of eye, nerve and kidney disease compared with standard glucose control, but the groups did not differ in the rate of progression to kidney failure, nerve disease, and major vision loss," said lead author Faramarz Ismail-Beigi, M.D., Ph.D., of Case Western Reserve University, Cleveland.

The ACCORD clinical study compared the effect of intensive control of blood sugar, blood pressure, and blood lipids to standard, less-intensive treatments on the risk of major cardiovascular events in more than 10,000 adults with established type 2 diabetes. The study's intensive glycemia arm was halted in February 2008 due to excess deaths in that group. At that time, participants in the intensively treated group were moved to standard glucose control.

At enrollment, ACCORD participants averaged 62 years of age and were obese. In addition to having type 2 diabetes for an average of 10 years, about one-third had pre-existing heart disease, and the remainder had at least two additional cardiovascular disease risk factors. They also had high blood sugar, as measured by the hemoglobin A1C test, which shows average blood sugar in the preceding two to three months. Half of participants had an A1C over 8.1 percent — above the currently recommended target for good control. A1C values in people without diabetes are less than 6 percent.

Previously reported results showed that over about three-and-a-half years of follow up, participants in the intensive blood sugar group had a 22 percent higher risk of death (5 percent versus 4 percent) and a three times higher risk of seriously low blood sugar (10.5 percent versus 3.5 percent) compared with participants in the standard blood sugar control group.

A secondary goal of the ACCORD blood sugar trial was to determine the effects of near-normal glucose control compared with standard control on microvascular, or small blood vessel, damage to organs and tissues. Earlier, well conducted clinical trials in patients with newly diagnosed type 1 and type 2 diabetes had proven lowering blood sugar levels reduced eye, nerve and kidney disease. ACCORD builds on this earlier data by studying benefits of further reduction of glucose to targets near normal, and by studying participants with long-standing rather than newly diagnosed diabetes.

In ACCORD, the A1C target for the intensively treated group was less than 6 percent, a level seen in adults without diabetes and significantly lower than the levels tested in earlier trials. The goal for standard control was an A1C of 7 to 7.9 percent, an average range achieved by individuals treated for type 2 diabetes in the United States. Both groups were treated with Food and Drug Administration-approved diabetes medications, as prescribed by their study clinician.

Eye, nerve, and kidney complications in the two groups were compared after 3.7 years, when intensive control was halted, and again at the study’s end after 5 years. When intensive glucose treatment was halted in the group receiving such treatment, half those participants had an A1C of 6.4 percent or lower, which rose to 7.2 percent at study end. In the standard treatment group, that A1C measure was 7.5 percent, rising to 7.6 percent by the end of the study.

The treatment groups did not differ in the rate of progression to kidney failure, major vision loss, or advanced peripheral neuropathy, a common nerve problem in diabetes that usually begins as tingling or numbness in the feet. However, people in intensive control had less deterioration in a vision test, and 20 percent fewer cataract surgeries compared with those in standard control. They also had a 30 percent lower rate of protein leakage in the urine, a sign of kidney disease and increased risk of heart disease. Testing for vibratory sensation, an indicator of nerve health, showed no difference between the groups, but the intensively controlled group scored better on other nerve tests.

ACCORD is continuing follow-up to assess whether the early changes seen in this study will result in differences in blindness, nephropathy and neuropathy. “The study had a relatively short time period – 3.7 years – to see significant differences in serious complications. Diabetes is a chronic disease, and prevention of complications should be measured over many years,” said Ismail-Beigi.

The effects of intensive blood sugar control on vision are consistent with findings from the ACCORD Eye Study, which explored the effects of intensive treatments on progression of diabetic retinopathy in a subset of about 3,000 ACCORD participants. The most common cause of vision loss in working-age Americans, diabetic retinopathy is a disease in which blood vessels in the eye’s light-sensitive retinal tissue are damaged by diabetes. Intensive blood sugar control was found to be beneficial in retarding the progression of diabetic retinopathy.

"ACCORD provides important data on the risks and benefits of intensive glucose control in people with established type 2 diabetes," said Susan B. Shurin, M.D., acting director of the NIH's National Heart, Lung, and Blood Institute (NHLBI). "Although increasing treatment to try to achieve near-normal blood sugar provides some benefit, clinicians and patients should note that this treatment strategy also potentially increases the risk of adverse effects in patients with additional risk factors for heart disease, such as those studied in ACCORD."

"Earlier landmark trials have proven that intensive glucose control early in the course of diabetes provides long-term benefits in reducing microvascular complications. ACCORD fills an important gap by studying adults with diabetes later in the disease and examining even more stringent glucose control than that previously proven beneficial," said Judith Fradkin, M.D., director of the Division of Diabetes, Endocrinology, and Metabolic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). "This new information will help tailor therapy for individuals with long established diabetes who are at high risk of cardiovascular events or already have cardiovascular disease."

About 24 million people in the United States have diabetes. It is the main cause of kidney failure, limb amputations, and new onset blindness in adults and a major cause of heart disease and stroke. Type 2 diabetes, which accounts for up to 95 percent of all diabetes cases, becomes more common with increasing age. It is strongly associated with obesity, physical inactivity, family history of diabetes, history of gestational diabetes (diabetes that occurs during pregnancy), and impaired glucose metabolism, and it is more common in minority groups. The prevalence of diagnosed diabetes has more than doubled in the last 30 years, due in large part to the upsurge in obesity and aging of the population.

The NHLBI is the primary sponsor of ACCORD, with additional funding and scientific expertise contributed by the NIDDK. Other components of the NIH — the National Institute on Aging and National Eye Institute — as well as the Centers for Disease Control and Prevention, supported sub-studies. The following companies provided study medications, equipment, or supplies: Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare Inc., GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals, Inc., Novo Nordisk, Inc., Omron Healthcare, Inc., Sanofi-Aventis U.S., and Takeda Pharmaceuticals Inc.

Part of the NIH, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov.

The National Institute of Diabetes and Digestive and Kidney Diseases, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include: diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

-----------Resources:

For further information about this trial (NCT00000620), visit www.clinicaltrials.gov or the ACCORD clinical trial website : www.accordtrial.org